Legislators to look at drug shortages

Andrea K. Walker, The Baltimore Sun

The staff at Anne Arundel Medical Center considered canceling some surgeries on a recent weekend because the hospital was running low on a common drug used to help bring people out from under anesthesia.

It is the kind of problem hospitals and doctors around the country continue to face as drug shortages that began a few years ago threaten the way everyday medicine is practiced.

The problem has persisted even after calls from Congress and President Barack Obama to find a solution and a federal investigation that found widespread abuses in the drug manufacturing and distribution system. Maryland lawmakers are jumping into the fray with plans to introduce legislation to tackle the issue at the state level.

On Tuesday, the Joint Committee on Health Care Delivery and Finance held a hearing to gather insights on what role the state could play.

Dr. Barry Meisenberg, chair of quality improvement and health systems research at Anne Arundel Medical Center, said the shortages force doctors to make tough decisions on how to treat patients. The hospital decided not to cancel surgeries that weekend, but Meisenberg said the issue was real.

"I used this as an example of how serious this has become," Meisenberg said.

Meisenberg and other medical professionals told the committee they have had to use alternative medicines and turn to more complicated procedures to treat ailments when it is hard to find a certain drug.

The issue has become so dire that Obama issued an executive order last year pushing the Food and Drug Administration to speed inspections of new drug facilities and to get drug companies to more quickly report shortages. The order also directed the FDA and the Justice Department to increase investigations of price gouging by pharmaceutical companies.

The FDA has said the number of drugs in short supply nearly tripled from 61 in 2005 to 178 in 2010. Most of the shortages involve intravenous drugs and generics. They include anesthetics, chemotherapy drugs, medicines that control infections and those used for patients in septic shock.

The shortages were created by a variety of factors, experts testified, such as quality-control problems at plants the FDA has had to shut down. Manufacturers are choosing not to produce drugs with low profit margins, such as generic forms, and instead have focused on those that bring in more money.

Manufacturers have said natural disasters, shortages of raw materials and changes in contracts with pharmacies and hospitals also are part of the problem.

University of Maryland women's basketball coach Brenda Freese became active in the cause after hearing about price gouging on the chemotherapy drug cytarabine, which was used to treat her son's leukemia.

Chris Knauer, an investigator with the House Oversight and Government Reform Committee, said drugs should make three stops — from a drug company to a distributor and lastly to a hospital or pharmacy. Instead, some pass through several distributors that mark up the price each time the drug changes hands, he said.

"This system makes little sense for patients who need the drugs and the hospitals that treat them," Knauer said.

The problem worsens as drugs are transported across state lines, Knauer said. A national database could help hold companies more accountable, he said.

Knauer also suggested that more investigation be done into whether drugs are kept safe as they are moved through the system. For instance, are they refrigerated properly?

Joint committee members said a solution is needed to keep patients safe. The panel's co-chairman Del. Dan K. Morhaim, the General Assembly's only doctor, said the committee will explore all these factors for possible legislation.

"We will get all the stakeholders together to figure out what to do," Morhaim said. "This is a critical clinical issue."